Quality Assurance Manager

6 months ago

Brisbane, Australia OnTalent Full time

ISO standards, 13485, approvals FDA, TGA etc
- QMS CI, Quality Champion
- MedTech product, complex systems

**About Magnetica**

We are recruiting for a motivated and focused Quality Assurance Manager to join our Brisbane-based team. A permanent, full-time position reporting to the General Manager, the role will suit someone looking to take responsibility for the quality aspects of a complex medical device. Primarily based in our Northgate office, this role can also include some remote and flexible work arrangements, by agreement.

Responsible for the Quality aspects of our business, this role will champion quality within our organisation and continue to drive a culture of quality throughout the business. As a rapidly growing company, this role provides the opportunity to directly contribute to our growth and success as we commercialise and deliver market-disrupting and regulatory compliant medical-device products.

**Your essential experience to meet the requirements of the role will include**:

- Being the internal champion for implementing, obtaining and retaining certifications in accordance with ISO 13485:2016, 21 CFR Part 820, and other applicable regulatory jurisdictions.
- Maintaining effectiveness and continuously improving Magnetica’s Quality Management System (QMS) including conducting Management Review Meetings.
- Managing the responses to audits (internal and external) including assigning and coordinating non-conformances as well as corrective and preventative actions and investigations.
- Maintaining the repository of controlled documents and managing their update and review processes.
- Being the Management appointed representative in terms of Magnetica’s QMS.
- Working with Magnetica’s technical domain experts, Regulatory Affairs Manager, General Manager, Production Manager, Supply Chain Manager and wider team, to ensure the timely delivery of market ready, QMS compliant product offerings throughout the overall product lifecycle.

**Your existing capabilities and skills will include**:

- Proven experience of Quality Assurance experience within the medical device/biotech industry.
- Demonstrated experience of successfully leading and influencing individuals and teams to embrace and support the delivery of QMS compliant products.
- Relevant qualification(s) in field(s) of Quality, Engineering and/or Biotech/Medtech.
- Experience of working within an ISO 13485 and/or 21 CFR Part 820 accredited organisation though certification and recertification cycles.
- Relevant auditing experience, ideally including a qualification (ISO 13485) or having received external training.
- Experience in management of design controls, collation of clinical evidence and transfer to manufacturing.
- Accuracy, attention to detail and a focus on task completion (a finisher).
- Being self-driven with good time management and prioritisation skills
- The ability to successfully collaborate with technical and non-technical staff.
- A flexible approach to dealing with changing priorities and demands.

Confidential enquiries can be made to Peter Starling, Senior Client Partner, on 07 3305 5830.

Magnetica

  • Quality Assurance Manager

    6 months ago

    Brisbane, Australia Allianz Australia Full time

    **Quality Assurance Manager | Consumer | Brisbane or Adelaide location** At Allianz, we’re proud to be one of the world’s leading insurance and asset management brands, with a workforce as diverse as the world around us. We care about our customers, which is why we hire the very best people to further our commitment to securing the future of our...

  • Quality Assurance Manager

    3 weeks ago

    Brisbane, Queensland, Australia World Fuel Services Full time

    Job OverviewWe are seeking an experienced Quality Assurance Manager to join our team at World Fuel Services. In this role, you will play a key part in ensuring the delivery of high-quality projects and services to our clients.

  • Manager, Quality Assurance Unit

    6 months ago

    Brisbane, Australia Queensland Curriculum and Assessment Authority Full time

    The QCAA is a statutory body of the Queensland Government established under the Education (Queensland Curriculum and Assessment Authority) Act 2014. In collaboration with a broad range of stakeholders and partner agencies, the QCAA plays a critical role in the design and delivery of education in Queensland. The Quality Assurance Unit is part of the QCAA's...

  • Anz Quality Assurance Manager

    8 months ago

    Brisbane, Australia OnTalent Full time

    Quality Assurance, standards, accreditation - Manufacturing, GMP, product R & D - Private scaling business, supporting growth This well-established privately owned business, head-quartered in New Zealand, is growing it’s Australian presence at a fast rate. Priding themselves on providing the agricultural industry with a range of innovative, world-class...

  • Quality Assurance Manager Aviation

    6 months ago

    Brisbane, Australia PERSOLKELLY Full time

    Our client a leading Aerospace company, is seeking a highly qualified Aviation Quality Assurance Manager to ensure the Company's compliance assurance management systems achieve world class levels of Operational Integrity. Our client a leading Aerospace company, is seeking a highly qualified Aviation Quality Assurance Manager to ensure the Company's...

  • Senior Quality Assurance Manager

    2 weeks ago

    Brisbane, Queensland, Australia KE Select Full time

    About the RoleThe ideal candidate will possess a deep understanding of biologics manufacturing processes, including RNA-based therapeutics, and have experience in quality assurance roles within the industry. They will be able to lead and manage all QA activities, ensuring compliance with FDA, EMA, and other regulatory requirements governing biologics...

  • Quality Assurance Manager

    4 weeks ago

    Brisbane, Queensland, Australia World Fuel Services Full time

    About This RoleWe are seeking a Quality Assurance Manager to join our team at World Fuel Services.Job DescriptionThe Quality Assurance Manager will be responsible for maintaining and monitoring compliance with our Project Management System and ensuring that all data, document, and record management systems meet the required standards.You will work closely...

  • Senior Quality Assurance Manager

    1 month ago

    Brisbane, Queensland, Australia Osborne Richardson Full time

    Quality Assurance Manager RoleOsborne Richardson is seeking a highly skilled and experienced Quality Assurance Manager to join their team in Brisbane. The successful candidate will have a strong background in food science or technology and a proven track record of improving quality systems and overall product quality.Responsibilities will include managing...

  • Quality Assurance Coordinator

    4 weeks ago

    Brisbane, Australia Powerlink Full time

    **At Powerlink, every possibility starts with you**: We believe life’s about possibilities. And so is the future. That’s why we need you. As the Quality Assurance Coordinator for our CopperString 2032 project you will provide project management and assurance support for the ongoing development, implementation and improvement of the Project assurance...

  • Head of Quality Assurance

    6 months ago

    Brisbane, Australia KE Select Full time

    Biomanufacturing - GMP - New role due to growth. - Biologics - Nucleic Acid. **About The Company** Our client is a leading CDMO dedicated to the development, manufacturing, and distribution of nucleic acid products. They are committed to ensuring the safety, efficacy, and compliance of products to meet regulatory standards and exceed customer expectations....

  • Quality Assurance Coordinator

    6 months ago

    Brisbane, Australia Osborne Richardson Australia Full time

    **Salary**: $90,000-$100,000 **Location**: QLD - Brisbane **Ref**: ND/014249 **Description**: Osborne Richardson is currently working with a Brisbane food manufacturer as they are seeking a Quality Assurance Coordinator to join their team. Reporting to the Quality Assurance Manager, this position will see you maintaining quality standards across...

  • Quality Assurance Manager

    4 weeks ago

    Brisbane, Queensland, Australia HelloFresh Australia Full time

    Opportunity OverviewA dynamic and permanent full-time Quality Assurance Officer role has become available at HelloFresh Australia, a leading food tech company. Based in Karawatha, this position offers a unique chance to make a real impact in the industry.

  • Quality Assurance Officer

    4 months ago

    Brisbane, Australia Rheinmetall Defence Australia Pty Ltd Full time

    **Quality Assurance Officer** **Rheinmetall Defence Australia Pty Ltd in Brisbane** - Rheinmetall - / - **Quality Assurance Officer** - Ref.Nr.: - **AU01965** -: - Contract Type: - **Permanent Full-Time** WHAT WE ARE LOOKING FOR **About the Team** Reporting to the Quality Manager Operations, this role will work alongside a team of 8 Quality Assurance...

  • Quality Assurance Manager

    1 month ago

    Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

    Job DescriptionRole OverviewThe successful candidate will lead the Materials Management Team in a dynamic and fast-paced environment, driving key performance indicators and ensuring the site's management system is effective.Lead the Materials Management Team to establish and maintain critical metrics related to all key systems owned by the team.Collaborate...

  • Quality Assurance Officer

    6 months ago

    Brisbane, Australia Osborne Richardson Australia Full time

    **Salary**: $60,000 - $70,000 **Location**: QLD - Brisbane **Ref**: ND/014250 **Description**: Osborne Richardson is currently working with a Brisbane food manufacturer as they are seeking a Quality Assurance Officer to join their team. Reporting to the Quality Assurance Manager, this position will see you sampling and checking finished goods to ensure...

  • Quality Assurance Associate

    4 months ago

    Brisbane, Australia Tripak Pharmaceuticals Full time

    Tripak Pharmaceuticals Pty Ltd Capalaba, Brisbane QLD **On-site work only, no remote work offered.**: Tripak Pharmaceuticals is a leading Brisbane based Contract Manufacturer of over 700 personal care products. Due to continuing growth, there is an opportunity to join our talented Quality team in a permanent position. The role reports to the QA Manager....

  • Head of Quality Assurance

    3 months ago

    Brisbane, Australia KE Select Full time

    About The Company   Our client is a leading CDMO dedicated to the development, manufacturing, and distribution of nucleic acid products. They are committed to ensuring the safety, efficacy, and compliance of products to meet regulatory standards and exceed customer expectations. As part of their commitment to excellence, they are seeking a highly skilled...

  • Head of Quality Assurance

    4 weeks ago

    Brisbane, Australia KE Select Full time

    About The Company   Our client is a leading CDMO dedicated to the development, manufacturing, and distribution of nucleic acid products. They are committed to ensuring the safety, efficacy, and compliance of products to meet regulatory standards and exceed customer expectations. As part of their commitment to excellence, they are seeking a highly skilled...

  • Quality Assurance Director

    4 weeks ago

    Brisbane, Queensland, Australia KE Select Full time

    About KE SelectCompany OverviewKE Select is a leading recruitment firm specializing in Life Science & Medical Technology. With a strong presence in ANZ, Asia, and the UK, they have established themselves as a trusted partner for organizations within the Pathology, Life Science, Medical Device, and Clinical spaces.Job DescriptionWe are seeking an experienced...

  • Quality Assurance Technician

    6 months ago

    Brisbane, Australia Optimum Consulting Group Full time

    **The Company** Nu-Pure is a well-recognised, nationally focused manufacturing business manufacturing 100% Australian made beverages. They are the largest privately owned beverage manufacturing organisation in Australia and their vision is to provide more people with healthy, natural hydration. The business has continued on a steady growth trajectory since...